New Clinical Trials Rules In India – A Relief For Patients - ACRI India

aIndia has come up with a new set of clinical trials rules for the year 2019 , which covers lots of aspects about approvals, drugs import systems, orphan drugs, and compensation and monitoring. All these changes have been made only for the betterment of India’s healthcare systems and population health. Thus, these new clinical trials rules are definitely going to help patients too. Here’s how.

 

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Clinical Research To Fight Zika Virus - ACRI India

Zika fever is a mosquito-borne disease that typically causes asymptomatic or mild infection like fever and rash in humans. It is transmitted to people through the bite of an infected Aedes species mosquito. This is the same mosquito that transmits dangerous diseases like dengue, yellow fever, and chikungunya. There are a number of people who have been infected with the Zika virus in India, with the first case being reported on September 23 last year, increasing to almost a century by the end of October. Many cases being reported were those of pregnant women, which is the most risky scenario, because Zika virus infection during pregnancy can cause infants to be born with microcephaly and other congenital malformations, known as congenital Zika syndrome. These conditions can cause infants to be born with a very small head, which may lead to brain damage. In fact, Zika virus in pregnant women can cause complications like premature birth or miscarriage too.

 

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Indian Government Permits Scientific Research On Cannabis - ACRI India

Cannabis, although suggested as a sacred plant in the Vedas, had been banned in India due to drug abuse. It had been banned from cultivation and sale, while also being hindered from finding out its potential medical benefits. India prohibited cannabis, coca, and opium for any general cultivation or consumption as per the Narcotics Drug and Psychotropic Substances Act, 1985. However, this act allowed cannabis to be used for medical and scientific purposes.

 

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Permission granted for scientific research

But now, the Indian Government has permitted scientific research on cannabis, with the narcotics department sanctioning a research and development project to examine substances found in the plant. The narcotics department within the Union Finance Ministry has sanctioned a research and development project on compounds like cannabidiol and tetrahydrocannabinol found in cannabis. Cannabidiol has been found to be used in gels, oils, and medicinal usage; while tetrahydrocannabinol has been responsible for the psychoactive effect.

The plan

With the narcotics department sanctioning the project, the cannabis will be grown in a monitored way, at the Central Institute of Medicinal and Aromatic Plants in Uttar Pradesh and Uttarakhand. As per the plan, the Council of Scientific and Industrial Research and Central Institute of Medicinal and Aromatic Plants will work together on the genetic improvement of identification and selection of tetrahydrocannabinol, cannabidiol, and cannabinioderpene. This note has been sent to all the state governments and the Director of Narcotics Control in the Finance Ministry.

Benefits of cannabis

Generally, high levels of tetrahydrocannabinol are responsible for the psychoactive nature of cannabis; but cannabis with low content of this element can be used for industrial and horticultural purposes. It can also be used for biomass and the production of cannabis seed oil. Also, cannabidiol extracts can be used in oils and food supplements, while also having medicinal usage. Thus, if used correctly, cannabis and its extracts can be very helpful; and can be used to manage pain, epilepsy, cancer, and sickle cell anemia. To confirm this, the Indian Institute of Integrative Medicine in Jammu is working with the Council of Scientific and Industrial Research, and is also planning to conduct clinical trials along with the Tata Memorial Centre in Mumbai and the All India Institute of Medical Sciences.

Will the plan bring positive outcomes?

Earlier this year, the World Health Organization suggested re-categorizing cannabis in international law due to the growing evidence of its supporting of medical usage. Many countries out there have also legalized the sale of this drug for medicinal purposes. Now, we are to see how the scientific research for cannabis works out in India, and whether the drug can be approved for pain management or not. For many other such experiments, there is a huge team of clinical researchers in our country working shoulder to shoulder to bring improvement to our country’s healthcare. You can also be one of them by taking up the best clinical research training in Bangalore from a reputed institute like Avigna Clinical Research Institute, where you can learn from experienced mentors and get a legitimate certification that can help you work in top CROs, Bio-techs, and pharmaceutical companies.

 

How Can You Benefit With A Career In Clinical Research?

When you attain education from one of the top clinical research institutes in Bangalore, you can avail lots of benefits in the future by building a successful career in the clinical research industry.

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How Can Artificial Intelligence Transform The Clinical Trial Arena? - ACRI

The clinical trial field is already very challenging with researches being made over new ailments and improvements on old medications. So, anything done to overcome these challenges could be of great help. And, artificial intelligence (AI) is one such element, which when combined with Big Data, holds the potential to resolve many such challenges.

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Why And How Should You Learn Clinical Research?

The scope of clinical research in India is gradually rising over the past few years, and is expected to create huge opportunities by 2020. Many organizations have shifted their clinical research units to India as our country offers the most cost-efficient opportunities for conducting clinical trials.

It is true that in the past few years, India had not been able to ensure rapid technological transformation and capabilities for development of new drugs, and had also faced regulatory challenges between 2010 and 2012. However, with the government making certain rules, regulations, and policy alterations for the Indian clinical research industry, the industry has again seen a boom, making India one of the most preferable destinations in the world again. The huge patient pool, the availability of skilled professionals, and the low costs involved has compelled global clinical research organizations to relocate their research units to India for drug development activities.

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